For Patients

Sectral (acebutolol hydrochloride) is used to treat hypertension (high blood pressure) and heart rhythm disorders. It is a beta-blocker. This medication is available in generic form. Common side effects include dizziness, lightheadedness, drowsiness, tiredness, constipation, diarrhea, stomach upset/gas, nausea, trouble sleeping or unusual dreams your body adjusts to the medication.

The initial dosage of Sectral in uncomplicated mild-to-moderate hypertension is 400 mg. The usual initial dose of Sectral to treat ventricular arrhythmia is 400 mg daily given as 200 mg twice daily. Dosage may be increased gradually until an optimal response is obtained, generally 600 to 1200 mg per day. Sectral may interact with allergy treatments (or allergy skin-testing), clonidine, guanabenz, MAO inhibitors, diabetes medications, heart medications, medicine for asthma or other breathing disorders, cold medicines, stimulant medicines, or diet pills. Tell your doctor all medications you use. Sectral should be used only when prescribed during pregnancy. Newborns whose mothers have taken this drug near the date of delivery may have problems such as low blood pressure, low heart rate and low birth weight, and may require special medical monitoring. This drug passes into breast milk. Consult your doctor before breast-feeding.

Our Sectral (acebutolol hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Sectral (acebutolol) is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment increases. The following table shows the frequency of treatmentrelated side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received Sectral (acebutolol) , propranolol, or hydrochlorothiazide as monotherapy, or placebo.

TOTAL VOLUNTEERED AND ELICITED (U.S. STUDIES)

Body System/
Adverse Reaction

Sectral Propranolol Hydrochlorothiazide Placebo

(N=1002)
%

(N=424)
%

(N=178)
%

(N=314)
%

Cardiovascular

Chest Pain

2

4

4

1

Edema

2

2

4

1

Central Nervous System

Depression

2

1

3

1

Dizziness

6

7

12

2

Fatigue

11

17

10

4

Headache

6

9

13

4

Insomnia

3

6

5

1

Abnormal dreams

2

3

0

1

Dermatologic

Rash

2

2

4

1

Gastrointestinal

Constipation

4

2

7

0

Diarrhea

4

5

5

1

Dyspepsia

4

6

3

1

Flatulence

3

4

7

1

Nausea

4

6

3

0

Genitourinary

Micturition (frequency)

3

1

9

<1

Musculoskeletal

Arthralgia

2

1

3

2

Myalgia

2

1

4

0

Respiratory

Cough

1

1

2

0

Dyspnea

4

6

4

2

Rhinitis

2

1

4

<1

Special Senses

Abnormal Vision

2

2

3

0

The following selected (potentially important) side effects were seen in up
to 2% of Sectral (acebutolol) patients:

Liver and Biliary System: A small number of cases of liver abnormalities
(increased SGOT, SGPT, LDH) have been reported in association with acebutolol
therapy. In some cases increased bilirubin or alkaline phosphatase, fever, malaise,
dark urine, anorexia, nausea, headache, and/or other symptoms have been reported.
In some of the reported cases, the symptoms and signs were confirmed by rechallenge
with acebutolol. The abnormalities were reversible upon cessation of acebutolol
therapy.

The incidence of drug-related adverse effects (volunteered and solicited) according
to Sectral (acebutolol) dose is shown below. (Data from 266 hypertensive patients treated
for 3 months on a constant dose.)

Body System

400 mg/day
(N=132)

800 mg/day
(N=63)

1200 mg/day
(N=71)

Cardiovascular

5%

2%

1%

Gastrointestinal

3%

3%

1%

Musculoskeletal

2%

3%

4%

Central Nervous System

9%

13%

17%

Respiratory

1%

5%

6%

Skin

1%

2%

1%

Special Senses

2%

2%

6%

Genitourinary

2%

3%

1%

Potential Adverse Events

In addition, certain adverse effects not listed above have been reported with
other β-blockingagents and should also be considered as potential adverse
effects of Sectral (acebutolol) . Central Nervous System: Reversible mental depression progressing
to catatonia (an acute syndrome characterized by disorientation for time and
place), short-term memory loss, emotional lability, slightly clouded sensorium,
and decreased performance (neuropsychometrics). Cardiovascular: Intensification
of AV block (see CONTRAINDICATIONS).

Miscellaneous: Reversible alopecia and Peyronie's disease. The oculomucocutaneous
syndrome associated with the β-blocker practolol has not been reported
with Sectral (acebutolol) during investigational use and extensive foreign clinical experience.